Registration Dossier

Administrative data

Description of key information

Combined repeated dose toxicity study in male and female Wistar rats (OECD TG 422, GLP):
NOAEL = 300 mg/kg bw; LOAEL = 1000 mg/kg bw.

Key value for chemical safety assessment

Mode of Action Analysis / Human Relevance Framework

Additional information

A combined repeated dose toxicity study in male and female Wistar rats was performed according to OECD TG 422 and GLP to assess the toxicity of the test substance after repeated exposure. Ten animals per sex were treated once daily per gavage with 100, 300, and 1000 mg/kg bw test substance. No test substance related clinical signs or effects on food consumption/body weight were observed throughout the test and recovery period in any of the dose groups. In the 100 and 300 mg/kg bw treatment groups no histopathological findings were observed. In the high-dose group livers of males and females showed a significantly increased incidence of hepatocellular hypertrophy. The change was considered reversible as the incidence was not significantly increased in the high dose recovery animals. Thus, a NOAEL of 300 mg/kg bw and a LOAEL of 1000 mg/kg bw (based on hepatocellular hypertrophy) was deduced.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

- No classification required.

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008 (last amended by EC/286/2008 (2011-03-10)):

- No classification required.